2940 nm Er: Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). With microbeam end piece it is indicated for Skin resurfacing.

Device Description

2940nm Er:YAG handpiece is the same as the one cleared with Quanta Forte platform (K152714), with the addition of a microbeam end piece. 2940nm Er:YAG is an handpiece that can work in conjunction with Quanta System FDA cleared devices (Quanta Forte and EVO and Discovery Pico Platform) provided with a suitable connector for recognizing and controlling the handpiece. Its emission is triggered by means of a footswitch connected to the console of the device it is used with.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification from the FDA for a medical device called the "2940 nm Er:Yag Laser Handpiece." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or meeting specific performance criteria through novel studies.

Therefore, the document does not contain the acceptance criteria and study details that would typically be associated with performance evaluation for a new, innovative device proving clinical effectiveness. Instead, it relies on demonstrating that the new handpiece is sufficiently similar in technology and intended use to existing cleared devices to be considered safe and effective.

Here's a breakdown of why the requested information is not available in the provided text:

Acceptance Criteria for Performance: The document states, "There are no mandatory performance standards for this device." This means there aren't pre-defined quantitative thresholds (like sensitivity, specificity, or image quality metrics) that the device must meet. The FDA's evaluation for a 510(k) is primarily about substantial equivalence.
Study Proving Device Meets Acceptance Criteria: Since no specific performance acceptance criteria are defined, there is no corresponding study designed to prove the device meets those criteria in the way one might expect for a diagnostic or novel therapeutic device.

However, the document does contain information about performance data provided in support of the substantial equivalence determination. This includes:

A table of acceptance criteria and the reported device performance:

Characteristic	Acceptance Criteria (Not explicitly stated as such, but rather characteristics for substantial equivalence comparison)	Reported Device Performance (2940 nm Er:YAG Laser Handpiece)
Safety & EMC	Compliance with IEC 60601-1, IEC 60601-2-22, IEC 60601-1-2	Complies with IEC 60601-1, IEC 60601-2-22 (safety) and IEC 60601-1-2 (EMC)
Software V&V	Verification and Validation according to FDA Guidance for Software in Medical Devices	Successfully underwent verification and validation testing, documentation provided as recommended by FDA guidance.
Histological Performance	Substantially equivalent skin resurfacing effects to predicate devices with a microlens array.	Histological performance data are provided to demonstrate substantially equivalent skin resurfacing effects to its predicate devices with a microlens array.
Biocompatibility	Established based on predicate devices.	Biocompatibility established based on predicate devices.
Technological Similarities to Predicates	(Various parameters listed in the "Summary of technological similarities and differences" table)	See the detailed table below for comparison to primary and additional predicates.

Technological Comparison Table from Document (Summarized):

Specifications	Subject Device (2940 nm Er:YAG Laser Handpiece)	Primary Predicate (Quanta Forte - K152714)	Additional Predicate (Fotona F-22/FS-01 Laser Handpiece - K132806)	Additional Predicate (MicroSpot Handpiece - K152153)
Laser medium	Er:YAG	Er:YAG	Er:YAG	Er:YAG
Wavelength [nm]	2940	2940	2940	2940
Energy, max [J]	3	3	3	2.5
Fluence [J/cm²]	Up to 95 (non-microbeam); Up to 121 (with stacking – microbeam)	Up to 95 (non-microbeam)	Up to 300 (stacking – microbeam)	Up to 51 (stacking – microbeam with 600 µm dots); Up to 150 (stacking – microbeam with 300 µm dots)
Pulse duration [ms]	0.3 to 1.5 ms	1 to 1.5 ms	0.1 to 1.5 ms	0.1 - 1.0 ms
Repetition rate, max [Hz]	6	5	50	20
Spot size	Ø 2, 4, 9mm; Ø 9mm dots array	Ø 2, 4, 9mm	13x13 mm dots array	13x13 mm dots array

Sample size used for the test set and the data provenance: This information is not provided in the document. The document refers to "histological performance data" but does not detail the study design, sample size, or data provenance (e.g., country, retrospective/prospective nature).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. As there's no mention of a clinical "test set" with expert adjudicated ground truth the way you'd find for an AI diagnostic device, these details are absent.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided for the same reasons as point 3.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This type of study is completely irrelevant to the device described (a laser handpiece for dermatological procedures) and is therefore not mentioned or performed. This is not an AI diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This device is a surgical laser handpiece; it does not operate as a standalone algorithm. Its performance is directly tied to its physical interaction with tissue under human control. Therefore, this concept is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The document mentions "histological performance data" for skin resurfacing effects. This implies that the ground truth for evaluating the laser's effect on tissue would likely be pathology/histology reports or visual assessment of tissue changes, compared to the effects achieved by predicate devices. However, the exact nature of this "ground truth" and how it was established for the comparison is not detailed.
The sample size for the training set: This device is a physical medical instrument, not an AI model that requires a training set. Therefore, this question is not applicable.
How the ground truth for the training set was established: This question is not applicable as there is no AI training set for this device.

In summary:

The provided FDA 510(k) document is for a physical medical device (laser handpiece), not an AI diagnostic tool. Therefore, many of the questions related to AI performance metrics, expert adjudication, and training/test sets are not applicable or detailed in this type of submission. The "study" mentioned mainly involves demonstrating compliance with electrical safety, EMC standards, and providing histological data to show comparable effects to predicate devices, thereby establishing substantial equivalence.

Summary

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December 13, 2017

Quanta System S.p.A. Francesco Dell'antonio V.P. Regulatory Affairs and Quality Assurance Via Acquedotto, 109 Samarate, IT 21017 VA

Re: K173002

Trade/Device Name: 2940 nm Er: Yag Laser Handpiece Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: September 18, 2017 Received: September 27, 2017

Dear Francesco Dell'antonio:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson -53

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K173002

Device Name 2940 nm Er: Yag Laser Handpiece

2940 nm Er: Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as,

but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi;

Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).

With microbeam end piece it is indicated for Skin resurfacing.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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5. 510(K) SUMMARY

Introduction:

This document contains the 510(k) Summary for the 2940 nm Er:YAG handpiece. The content of this summary is based on the requirements of 21 CFR 807.92(c).

Applicant / Manufacturer Name and Address:	Quanta System SPAVia Acquedotto, 109Samarate (VA)Italy 21017
510(k) Contact Person:	Francesco Dell'AntonioV.P. Regulatory Affairs and Quality AssuranceQuanta System S.p.A.Email: francesco.dellantonio@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815
Date Prepared:	12/11/2017
Device Name:	2940 nm Er:YAG laser handpiece
Classification:	Class II
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology.
Regulation Number:	21 CFR 878.4810
Product Code:	GEX

Predicate Devices:

The modified device 2940nm Er:YAG handpiece is derived from the legally marketed (unmodified) device 2940nm handpiece cleared under Quanta Forte platform (K152714).

2940nm Er:YAG handpiece is substantially equivalent to the following legally marketed predicate devices:

Primary predicate: K152714 Quanta Forte - QUANTA SYSTEM SPA Additional predicate:
K132806 FOTONA F-22 LASER HANDPIECE, FOTONA FS-01 LASER HANDPIECE - FOTONA D.D.
. K152153 MicroSpot Handpiece - ASCLEPION LASER TECHNOLOGIES GMBH

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Performance Standards:

There are no mandatory performance standards for this device.

Description of the device:

2940nm Er:YAG handpiece is the same as the one cleared with Quanta Forte platform (K152714), with the addition of a microbeam end piece.

2940nm Er:YAG is an handpiece that can work in conjunction with Quanta System FDA cleared devices (Quanta Forte and EVO and Discovery Pico Platform) provided with a suitable connector for recognizing and controlling the handpiece.

lts emission is triggered by means of a footswitch connected to the console of the device it is used with.

Intended use

2940 nm Er:Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).

With microbeam end piece it is indicated for Skin resurfacing.

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Summary of technological similarities and differences of the new device in comparison with the predicate

Specifications	Subjected device	Original(unmodifieddevice)	additional predicate device
Trade/Device Name	2940 nm Er:YAGLaser Handpiece	Quanta Forte	Fotona F-22/FS-01 LaserHandpiece (F-RUNNER)	MicroSpotHandpiece
510(K) #	-	K152714	K132806	K152153
Submitter	Quanta SystemS.p.A.	Quanta SystemS.p.A.	FOTONA D.D.	Asclepion LaserTechnologies GmbH
Laser medium	Er:YAG	Er:YAG	Er:YAG	Er:YAG
Wavelength[nm]	2940	2940	2940	2940
Energy, max[J]	3	3	3	2.5
Fluence[J/cm²]	Up to 95 (nonmicrobeam mode);Up to 121 (withstacking pulses –microbeam mode)	Up to 95 (nonmicrobeammode);	Up to 300(stacking pulses– microbeammode)	Up to 51 (stackingpulses - microbeammode with 600 µmdots)Up to 150(stacking pulses –microbeam modewith 300 µm dots)
Pulse duration[ms]	0.3 to 1.5 ms	1 to 1.5 ms	0.1 to 1.5 ms	0.1 -1.0 ms
Repetition rate,max[Hz]	6	5	50	20
Spot size	Ø 2, 4, 9mmØ 9mm dots array	Ø 2, 4, 9mm	13x13 mm dotsarray	13x13 mm dotsarray

Performance data:

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The following performance data are provided in support of the substantial equivalence determination, for the Er:YAG handpiece used in conjunction with the devices it is intended to be used with.

Safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Quanta Forte device.

The system complies with the IEC 60601-1, IEC 60601-2-22 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

The Er:YAG handpiece does not contain any software, as it is controlled by the software of the devices it is used in conjunction with (already FDA cleared). Those software were not modified due to the use with the microbeam Er:YAG handpiece.

They successfully underwent verification and validation testing and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Histological performance data are provided to demonstrate substantially equivalent skin resurfacing effects to its predicate devices with a microlens array.

Biocompatibility:

The biocompatibility of the Er:YAG handpiece is established based on the predicate devices.

Conclusion:

The subject device is comparable to its primary predicate and the additional predicate devices as it has similar intended use and core fundamental technology as show in the SE table above.

Therefore, Er:YAG handpiece is substantially equivalent to its identified predicate devices.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.